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Patient anxiety prior to invasive procedures poses a significant barrier to successful treatment if not well-managed. The purpose of this study is to evaluate lavender aromatherapy, a non-sedating alternative, to reduce anxiety prior to interventional spinal procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (+aromatherapy) group | Experimental |
| |
| Control (-aromatherapy) group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated Lavender Elequil aromatabs® (#372) | Other | Activated Lavender aromatherapy tablets wrapped in tape |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6) | The STAI-6 is a six-item assessment of state anxiety. Each item is assessed on a four-point Likert scale. Scores on the STAI-6 range from 6-24, with a higher score indicating greater state anxiety. | Administered within 30 minutes before and 30 minutes after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Vasovagal Events during Standard of Care Spine Procedure | All vasovagal events that occur during the standard of care spine procedure will be recorded and reported | Assessed within 30 minutes following the standard of care spine procedure |
| Number of Aborted Standard of Care Spine Procedures |
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Inclusion Criteria:
Males and females between 18-85 years old
Scheduled for one of the following procedures on the day of consent:
Able to provide informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaspal R Singh, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.
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| ID | Term |
|---|---|
| D004194 | Disease |
| D001416 | Back Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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For the treatment group, the aromatherapy tablets will be activated for max aromatherapy. For the control group, the tablets will not be activated and will be devoid of scent. For both groups, the tablet will be wrapped in masking tape to maintain the blind for subjects.
| Unactivated Lavender Elequil aromatabs® (#372) | Other | Unactivated Lavender aromatherapy tablets wrapped in tape |
|
| Assessed within 30 minutes following standard of care spine procedure completion or abortion |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |